Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-27 @ 3:11 AM
Study NCT ID:
NCT02007902
Status:
COMPLETED
Last Update Posted:
2018-10-01
First Post:
2013-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Protein Levels and Very Preterm Birth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-28', 'studyFirstSubmitDate': '2013-11-25', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of clinical hemodynamic disturbances defined by arterial hypotension (non-invasive measure of MAP - mmHg - pathological for gestational age) or measured at organ colour doppler, echocardiography or NIRS', 'timeFrame': 'about 6 hours after birth'}], 'secondaryOutcomes': [{'measure': 'plasma protein', 'timeFrame': 'at 1 second after birth (cord blood sample)', 'description': 'plasma protein level on cord blood sample depending on maternal and neonatal variables'}, {'measure': 'Albumin level', 'timeFrame': 'At 12 hours after birth'}, {'measure': 'Mortality rate', 'timeFrame': 'patients will be followed for the duration of hospital stay, that is an average of 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preterm baby', 'Total plasma protein', 'Albumin', 'Hemodynamic disturbances', 'Perfusion', 'Near Infra Red Spectroscopy (NIRS)', 'Ultrasound'], 'conditions': ['Very Preterm Infants']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to investigate the relationship between early plasma protein levels and hemodynamics in very preterm infants during postnatal transition. Secondary aims are the following: i) to evaluate maternal and neonatal factors affecting plasma protein level at birth; ii) to evaluate the relationship between plasma protein level and albumin level on the first day of life; iii) to evaluate the association between early hypoproteinemia and neonatal mortality and morbidity in very preterm infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Hour', 'minimumAge': '1 Minute', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Very preterm infants with birth at less than 32 weeks of gestational age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents written informed consent\n* Birth at less than 32 weeks of gestational age\n* Birth in a III level delivery facility at Reunion Island\n\nExclusion Criteria:\n\n* Major congenital abnormalities'}, 'identificationModule': {'nctId': 'NCT02007902', 'acronym': 'ProHémie', 'briefTitle': 'Plasma Protein Levels and Very Preterm Birth', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Early Plasma Protein Levels and Neonatal Hemodynamics: a Prospective Evaluation in Very Preterm Infants', 'orgStudyIdInfo': {'id': '2013/CHU/02'}, 'secondaryIdInfos': [{'id': '2013-A00090-45', 'type': 'OTHER', 'domain': 'Agence Nationale de Sécurité du Médicament'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Very preterm babies', 'description': 'Observational model: cohort', 'interventionNames': ['Other: Evaluation of the relationship plasma protein levels - neonatal hemodynamics']}], 'interventions': [{'name': 'Evaluation of the relationship plasma protein levels - neonatal hemodynamics', 'type': 'OTHER', 'description': '* Patient inclusion at birth\n* Total plasma protein values measurement on cord blood sample at birth\n* Hemodynamic evaluation at 6 hours after birth with colour doppler echocardiography and organ blood flow colour doppler\n* Total plasma protein and albumin values measurement on plasma sample at 12 hours after birth\n* Blood pressure, heart rate, O2 saturation, capillary refill time, rSO2 \\[regional (cerebral and somatic) tissue oxygenation by NIRS - near infrared spectroscopy\\] will be monitored over 24 hours after birth.', 'armGroupLabels': ['Very preterm babies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97405', 'city': 'Saint-Denis', 'state': 'La Réunion', 'country': 'France', 'facility': 'Centre Hopsitalier Universitaire de La Réunion', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '97448', 'city': 'Saint-Pierre', 'state': 'La Réunion', 'country': 'France', 'facility': 'Centre Hospitalier de La Réunion', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}], 'overallOfficials': [{'name': 'Silvia Iacobelli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de La Réunion -Site du GHSR'}, {'name': 'Sylvain Samperiz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de La Réunion - Hôpital Félix Guyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'collaborators': [{'name': 'INSERM CIE1, Dijon, 21000, France', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}